Prosecutors Request Arrest Warrant for Former Kolon Chairman Lee Woong-yeol over 'Invossa Suspicion' (Comprehensive)
[Asia Economy Reporter Seongpil Cho] The prosecution has requested an arrest warrant for Lee Woong-yeol, former chairman of the Kolon Group (63), who is considered the ultimate person responsible for the controversy surrounding the osteoarthritis gene therapy drug Invossa-K (Invossa).
It has been about a year since the full-scale investigation began in June last year.
The Criminal Division 2 of the Seoul Central District Prosecutors' Office (Chief Prosecutor Changsoo Lee) announced on the afternoon of the 25th that it had requested an arrest warrant for former Chairman Lee on charges including violations of the Capital Markets and Financial Investment Business Act (fraudulent transactions, market manipulation, etc.) and breach of trust and mediation.
The pre-arrest interrogation (warrant hearing) for former Chairman Lee is expected to be held at the Seoul Central District Court as early as the afternoon of the 26th or at the latest on the morning of the 29th. The judge who will decide on the necessity of his detention has not yet been appointed.
Former Chairman Lee is accused of manufacturing and selling Invossa with a 'kidney-derived cell (GP2-293)' component, which differs from the 'chondrocyte' component approved by the Ministry of Food and Drug Safety (MFDS) from November 2017 to March last year.
Invossa is an osteoarthritis gene therapy injection composed of two components: Component 1 containing human chondrocytes and Component 2 containing genetically modified cells introduced with the chondrocyte growth factor (TGF-β1).
This injection was approved by the MFDS in 2017 as the first gene therapy in Korea. However, after it was revealed that the genetically modified cells in Component 2 were kidney cells capable of causing tumors, not chondrocytes as stated in the submitted documents at the time of approval, the approval was finally revoked in July last year.
Former Chairman Lee is also accused of knowing in July 2017 that Invossa contained kidney-derived cells instead of chondrocytes but concealed this fact and submitted false documents to obtain MFDS approval.
The prosecution believes that former Chairman Lee was also involved in Kolon TissueGene's 'stock listing fraud.' Kolon TissueGene, a subsidiary of Kolon Life Science that led the development of Invossa, was listed on the KOSDAQ market in 2017, leveraging the MFDS approval of Invossa.
The prosecution suspects that former Chairman Lee was involved in and received reports regarding Kolon TissueGene's use of false documents submitted during Invossa's MFDS approval process for the stock listing.
The prosecution summoned former Chairman Lee as a suspect for questioning on the 18th. This was his first appearance before the prosecution regarding the Invossa controversy since the investigation began in June last year.
In February, the prosecution indicted Kolon Life Science CEO Woo-seok Lee (63) on charges including violations of the Pharmaceutical Affairs Act, the Capital Markets Act, and the Subsidy Management Act, among seven charges, and detained him. Kolon Life Science and Kolon TissueGene were also indicted without detention under the principle of corporate liability.
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In December last year, the prosecution successively indicted three individuals on charges related to the clinical development field and Kolon TissueGene's stock listing fraud case: Director Mo Cho, former CFO Mo Kwon of Kolon TissueGene, and Head of Department Mo Yang of Kolon Life Science, all of whom were detained.
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